MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC

Model Number TPL0038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Tissue Damage (2104); Impaired Healing (2378)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

Date of event. Please note that this date is based off the date of publication of the article as the actual event date was not provided. The reported event was from the following literature article: keric n, doenitz c, haj a, rachwal-czyzewicz i, renovanz m, wesp d, boor s, conrad j, brawanski a, giese a, kantelhardt s. Evaluation of robot-guided minimally invasive implantation of 2067 pedicle screws. Neurosurgical focus. 2017. 42 (5). Doi: 10. 3171/2017. 2. Focus16552. (b)(4). If information is provided in the future, a supplemental report will be issued. (b)(4).

Event Description

Abstract: recent studies have investigated the role of spinal image guidance for pedicle screw placement. Many authors have observed an elevated placement accuracy and overall improvement of outcome measures. This study assessed a bi-institutional experience following introduction of the renaissance miniature robot for spinal image guidance in europe. The medical records and radiographs of all patients who underwent robot-guided implantation of spinal instrumentation using the novel system (between october 2011 and march 2015 in mainz and february 2014 and february 2016 in regensburg) were reviewed to determine the efficacy and safety of the newly introduced robotic system. Screw position accuracy, complications, exposure durations to intraoperative radiation, and reoperation rate were assessed. Of the 413 surgeries that used robotic guidance, 406 were via a minimally invasive approach. In 7 cases the surgeon switched to conventional screw placement, using a midline approach, due to referencing problems. Atotal of 2067 screws were implanted using robotic guidance, and 1857 screws were evaluated by postoperative ct. Of the 1857 screws, 1799 (96. 9%) were classified as having an acceptable or good position, whereas 38 screws (2%) showed deviations of 3¿6 mm and 20 screws (1. 1%) had deviations > 6 mm. Nine misplaced screws, implanted in 7 patients, required revision surgery, yielding a screw revision rate of 0. 48% of the screws and 7 of 406 (1. 7%) of the patients. The mean ± sd per-patient intraoperative fluoroscopy exposure was 114. 4 (± 72. 5) seconds for 5. 1 screws on average and any further procedure required. Perioperative and direct postoperative complications included hemorrhage (2 patients, 0. 49%) and wound infections necessitating surgical revision (20 patients, 4. 9%). The hexapod miniature robotic device proved to be a safe and robust instrument in all situations, including those in which patients were treated on an emergency basis. Placement accuracy was high; peri- and early postoperative complication rates were found to be lower than rates published in other series of percutaneous screw placement techniques. Intraoperative radiation exposure was found to be comparable to published values for other minimally invasive and conventional approaches. Reported events: 1 - 5 patients who underwent procedures using the robotic guidance system required revision surgeries for screw deviations. 2 - 2 patients who underwent procedures using the robotic guidance system required revision surgeries for anterior vertebral perforation and contact with the abdominal aorta. 3 - 20 patients who underwent procedures using the robotic guidance system experienced problems with wound healing and needed a revision surgery. 4 - 2 patients who underwent procedures using the robotic guidance system experienced postoperative csf-fistula and wound healing problems that required a revision surgery. 5 - a patient who underwent a procedure using the robotic guidance system experienced new neurological deficits post-operatively and a revision surgery was required. The patient experienced paraplegia due to an epidural thoracic hematoma, immediately underwent reoperation and had recovered. 6 - a patient who underwent a procedure using the robotic guidance system experienced new neurological deficits post-operatively and a revision surgery was required. The patient experienced nerve root injury due to a misplaced screw. Reoperation was completed immediately and the patient recovered. 7 - 4 patients who underwent procedures using the robotic guidance system experienced pneumonia during the postoperative course. 8 - 2 patients who underwent procedures using the robotic guidance system experienced pulmonary embolism during the postoperative course.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8904456
• MDR Text Key: 156900736
• Report Number: 1723170-2019-04515
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/18/2019 Patient Sequence Number: 1